FDA Inspection
Biokosmes SrlBiokosmes Srl – FDA Inspection, Sep 22, 2017
Record Details
This FDA Inspection record concerns Biokosmes Srl, with an inspection on September 22, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
- Person
- Rita K. Vick (Issuing Officer)
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ID · d25416a6-c85d-4df0-b260-5a04ce488f21
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1027634
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
9- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.25(a)GMP Training Frequency
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.125(a)Strict control not exercised over labeling issued
- 21 CFR 211.160(b)(4)Instruments, apparatus, et. al. not meeting specs
- 21 CFR 211.166(a)(1)Sample size - test intervals
- 21 CFR 211.111Establishment of time limitations
- 21 CFR 211.180(e)(2)Items to cover on annual reviews
- 21 CFR 211.160(b)(1)Sampling and testing procedures described
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Other FDA inspections of Biokosmes Srl
3| Date | Classification | Office | Project area |
|---|---|---|---|
| December 2, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 29, 2014 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 18, 2010 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Biokosmes Srl
- FDA Inspection 1191833 - 2022-12-02
- FDA Inspection 884487 - 2014-05-29
- FDA Inspection 700525 - 2010-11-18
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